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Multicenter, Prospective, Non-randomized, Single-arm, Interventional Study for the Evaluation of the Safety and Preformance of the SRS Device for the Treatment of Pelvic Organ Prolapse

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03195361
Recruitment Status : Active, not recruiting
First Posted : June 22, 2017
Last Update Posted : August 16, 2019
Sponsor:
Information provided by (Responsible Party):
Lyra Medical Ltd.

Brief Summary:
A prospective, single arm, multi-center clinical study to evaluate the safety and performance of the SRS (Lyra Medical) vaginal mesh in POP patients

Condition or disease Intervention/treatment Phase
Anterior Vaginal Wall Prolapse With/Without Apical/Uterine Descent Device: SRS - Self Retaining Support system Not Applicable

Detailed Description:
The SRS implant is intended for transvaginal surgical treatment of anterior vaginal wall prolapse with or without vaginal apex/uterine prolapses

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Actual Study Start Date : March 2016
Estimated Primary Completion Date : August 2020
Estimated Study Completion Date : August 2020

Arm Intervention/treatment
Experimental: Single-arm
Subjects suffering from anterior POP-Q grade 2 (point Aa and Ba≥ -1) and above, who are scheduled for POP surgery, will be transplanted with the SRS device
Device: SRS - Self Retaining Support system
Other Name: transvaginal surgical treatment




Primary Outcome Measures :
  1. Improvement in POP-Q points Aa and Ba [ Time Frame: 36 months ]
    Points Aa and\or Ba are less than -1

  2. Improvement in POP-Q point C: [ Time Frame: 36 months ]
    Point C at -5 or less

  3. No unexpected serious adverse device related events [ Time Frame: 36 months ]

Secondary Outcome Measures :
  1. Achieving normal urinary function: [ Time Frame: 36 Months ]
    Patient does not experience voiding dysfunction and have negative Urinary Cough Test.

  2. Improvement in Quality Of Life (QoL) [ Time Frame: 36 Months ]
    Subjective bother involving pelvic floor disorders using validated scales including PFDI-20 and PSIQ-12.



Information from the National Library of Medicine

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Ages Eligible for Study:   50 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Patient has signed the informed consent form and is willing to participate in the clinical study and data collection.
  2. Patient age is between 50 and 75 years old
  3. POP-Q: Aa and/or Ba is at least -1

Exclusion Criteria:

  1. Patient is pregnant or breastfeeding
  2. Patient is suffering from active infection (on antibiotic therapy)
  3. Patient is planning vaginal delivery
  4. Patient had previous vaginal mesh surgery
  5. Patient is in high risk for surgery (evidence of clinically significant cardiovascular, renal, hepatic, coagulatory or respiratory diseases).
  6. Any condition that in the judgment of the investigators would interfere with the subject's ability to provide informed consent, comply with study instructions, place the subject at increased risk, or which might confound interpretation of study results.
  7. Malignancy.
  8. Known hypersensitivity to PEEK and/or polypropylene materials.
  9. Participation in another investigational trial that has not completed the primary endpoint or interferes with study participation.
  10. Diagnosed with mental or emotional disturbance.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03195361


Locations
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Israel
Mayanei HaYeshua Medical Center
Bnei Brak, Israel, 51544
Ziv Medical center
Safed, Israel
Asaf HaRofeh Medical Center
Zrifin, Israel, 70300
Sponsors and Collaborators
Lyra Medical Ltd.

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Responsible Party: Lyra Medical Ltd.
ClinicalTrials.gov Identifier: NCT03195361    
Other Study ID Numbers: CD-14-011
First Posted: June 22, 2017    Key Record Dates
Last Update Posted: August 16, 2019
Last Verified: August 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Prolapse
Pathological Conditions, Anatomical